Articles, App Notes, Case Studies, & White Papers

1. Data-Driven Approach Optimizes Robust, Scalable Lyophilization Process

   Selecting the right manufacturing partner with appropriate lyophilization expertise, experience, and analytical capabilities can speed drug development and expedite time to market for lyophilized drugs.

2. Annex 1 – The Brave New World Of Regulatory Compliance 2/3/2023

   The revision to Annex 1 will become effective in August 2023. Explore the major changes and considerations along with the next steps to achieve Annex 1 Regulatory compliance.

3. Selecting An Alternative Coating Technology To Silicone Oil For Prefillable Syringes 5/5/2022

   The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.

4. Lyophilization Contract Manufacturing Services: What To Know 3/7/2023

   Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.

5. Understanding Of Amorphous Solid Dispersions & Their Downstream Development 2/7/2022

   Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.

6. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

   Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

7. Container Selection For A Highly Sensitive Drug Product: A Success Story 8/27/2024

   Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.

8. The Growth Of Sterile Injectables 6/1/2023

   Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.

9. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

   Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

10. Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products 11/8/2021

    IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.